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U.S. Department of Health and Human Services

Class 2 Device Recall ELAN 4

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 Class 2 Device Recall ELAN 4see related information
Date Initiated by FirmSeptember 05, 2017
Create DateFebruary 15, 2018
Recall Status1 Terminated 3 on September 20, 2019
Recall NumberZ-0620-2018
Recall Event ID 79068
Product Classification Drills, burrs, trephines & accessories (simple, powered) - Product Code HBE
ProductELAN 4 Drill: ELAN 4 1-RING TWIST DRILL D1.5 ELAN 4 1-RING TWIST DRILL D2.0 ELAN 4 2-RING TWIST DRILL D1,0/4,0MM ELAN 4 2-RING TWIST DRILL D1,1/4,0MM ELAN 4 2-RING TWIST DRILL D1,2/4,0MM ELAN 4 2-RING TWIST DRILL D1,5/4,0MM ELAN 4 2-RING TWIST DRILL D1,5 ELAN 4 2-RING TWIST DRILL D2,0 ELAN 4 2-RING WIRE PASS DRILL D1.0 ELAN 4 2-RING WIRE PASS DRILL D1.5 ELAN 4 2-RING WIRE PASS DRILL D2.0 ELAN 4 2-RING WIRE PASS DRILL D1.0 ELAN 4 2-RING WIRE PASS DRILL D1.5 ELAN 4 2-RING WIRE PASS DRILL D2.0
Code Information All lots, Model Number: GP188R GP189R GP344R GP345R GP346R GP347R GP348R GP349R US804R US805R US806R US828R US829R US830R 
Recalling Firm/
Manufacturer		 Aesculap Implant Systems LLC
3773 Corporate Pkwy
Center Valley PA 18034-8217
For Additional Information ContactVal Strawn
610-984-9414 Ext. 5414
Manufacturer Reason
for Recall		ELAN 4 burr/blade accessories were marketed without 510(k) premarket notification clearance.
FDA Determined
Cause 2		No Marketing Application
ActionNotifications were sent requesting the customers immediately discontinue use and quarantine affected products. The notification explains that a sales representative will visit the facilities to remove affected product and return it to the firm.
Quantity in Commerce6211
DistributionDistributed to 4 hospitals in the following states: NM, OH, TX, WV
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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